Thyrogen Approved for Additional Thyroid Cancer Treatment
Tuesday December 18, 2007
Genzyme, the manufacturer of the drug Thyrogen (thyrotropin alfa for injection) has announced that the drug has received FDA approval to be used along with radioiodine (RAI) for the treatment known as "remnant ablation." The objective of remnant ablation is to destroy the remaining thyroid tissue in thyroid cancer patients who have had their thyroid surgically removed. Thyrogen is already in approved use for thyroid cancer patients who are having diagnostic scans to evaluate cancer recurrence.
In a Genzyme press release, the company's senior vice president Mike Heslop commented:
"This new indication extends the significant benefits of Thyrogen to patients during their initial treatment for thyroid cancer, in addition to its current use in follow-up diagnostic procedures to detect recurrence. This is an important milestone in our ongoing effort to expand the clinical applications of Thyrogen to improve patient care."Prior to radioactive scans or ablation for thyroid cancer, patients typically must be taken off their thyroid hormone hormone replacement medication, in order to ensure accuracy and effectiveness of the scans or RAI ablation. Thyrogen allows most thyroid patients to avoid the symptoms of hypothyroidism that usually result from going off their thyroid hormone replacement, without compromising the effectiveness and accuracy of scans and treatment.
The Genzyme press release describes remnant ablation and Thyrogen's role:
In remnant ablation, patients take a drink or a capsule that contains radioactive iodine, which is taken up by any remaining thyroid cells. To enhance the uptake of radioiodine, the level of thyroid stimulating hormone (TSH) in a patient's bloodstream must be enhanced. Patients currently stop taking thyroid hormone supplements to elevate TSH levels. Doing so, however, often causes side effects associated with hypothyroidism, which may include fatigue, difficulty concentrating, short-term memory impairment and depression. Thyrogen is a recombinant form of TSH that is administered by injection, allowing patients to continue taking hormone supplements and avoid the symptoms associated with hormone withdrawal. The FDA approved Thyrogen for remnant ablation based on results from a pivotal clinical study which suggest that treatment with Thyrogen is similar to withdrawal from thyroid hormone in achieving ablation, and that it could significantly reduce the side effects of thyroid hormone withdrawal by allowing patients to remain on hormone replacement therapy.More Information
Source: Genzyme Corp. press release, "Genzyme Announces FDA Approval of Thyrogen(R) for Use in Thyroid Cancer Ablation," Monday December 17, 9:31 am ET
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Comments
I have hurthle cell thyroid cancer. I had a total thyroidectomy. But the tumor had already invaded 3 vessels so the chances the cancer is already in my blood stream is probable. In spite of hurthle cell being iodine resistant and TSH resistant I am getting radio iodine to kill any remaining normal thyroid cells. Anyway, I also have Hashi’s, as well as secondary hypothyroidism due to a damaged pituitary. My TSH will not go up enough for the radio iodine by stopping meds.
I will be getting the thyrogen shots. What is not mentioned in the article is that thyrogen is considered a prescription drug. I have medicare and supplemental insurance but no prescription plan on either. I will be required to pay out of pocket the $1500 to $2000 (depending on how many shots and the price the hospital charges) for the shot. It is very expensive, especially if you do not have a prescription plan.